Job Details
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
What we offer you:
• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation and to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations. Responsibilities include managing multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes, establishing philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures, managing the activities of direct reports to accomplish scope of work of validation department, managing protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation, reviewing and approving facility equipment and software changes, evaluate and determine required validation testing, coordinating contract commissioning and validation services including contract review and approval, and overseeing the implementation of laboratory validation requirements.
The Position
Relationships
Reports to: Senior Manager or above
Direct Reports: 5 - 12
Essential Functions
• Media Fill Validation:
• Lead, design, execute, and analyze media fill simulations to qualify aseptic filling operations within isolators, ensuring compliance with regulatory and quality standards (FDA, EU GMP)
• Oversee all aspects of aseptic filling operations, ensuring the sterility of product environments, implementing contamination control strategies, and maintaining operational excellence in isolators
• Build aseptic team oversight of the filling processes
• Utilize microbiological knowledge to develop contamination control strategies, interpret/support microbiological results from media fills, environmental monitoring, and sterility testing
• Ensure that applicable aseptic processing activities are compliant with current Good Manufacturing Practices (cGMP), ISO standards, and regulatory agency requirements
• Lead and mentor a team of aseptic processing and microbiology professionals, ensuring proper training and performance in aseptic techniques and isolator operations
• Prepare and maintain detailed reports of media fill results/reports, environmental monitoring data, and aseptic process validation
• Identify opportunities for process improvement in aseptic techniques, isolator efficiency, and overall contamination control strategies. Implement best practices and corrective actions
• Perform risk assessments related to aseptic processing, media fills, and microbial contamination Develop mitigation strategies for potential sterility risks
• Participate in regulatory audits, internal audits, and inspections related to aseptic processing, media fills, and microbial control
• Develop qualification strategies and documents for novel processes
• Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers and/or Engineers
• Strong understanding of guidance documents from FDA, EMA, PDA, ISPE, and other industry organizations
• Formal client communications including client memos as required for APS topics
• Review change controls for APS impact
• Lead response to client and regulatory requests and observations
• Other duties as assigned
• General Responsibilities:
• Supervises Validation personnel with oversight from management, including assignments and priorities, providing guidance, and serving as a resource for technical and administrative issues
• Oversee complex equipment validation projects
• Review and approve deviations relevant to validation
• Understand all validation technical disciplines, including equipment, cleaning, computer system validation, and process validation, and be able to integrate validation into broader projects
• Aware of regulatory trends, industry best practices, and technological improvements related to equipment validation
• Participate in new product introduction, deviation reviews, and other systems as senior SME for validation
• Lead response to regulatory requests and observations as required
• Onboards, trains, motivates, and leads Validation personnel with oversight from management
• Develops and maintains Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policies
• Provides guidance and oversight for commissioning, qualification, and validation of systems and processes
• Drafts, reviews, and executes plans, protocols, and reports related to commissioning, qualification, and validation of systems and processes. This includes associated protocol events
• Maintains systems and processes in the qualified and/or validated state, including performing and reviewing requalifications and periodic reviews
• Reviews change controls to assess impact to commissioned, qualified, and validated systems and processes
• Assists with validation topics during internal audits, including participating during audits, providing responses to audit observations, and completing corrective actions
• Serves as a quality contact and subject matter expert (SME) for simple qualified and/or validated systems and processes
• Implements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from management
• Leads cross functional teams for initiatives around simple qualified and/or validated systems and processes
• Independently oversees validation contractors
• Provides technical assistance and training to personnel
• Files and maintains controlled documents
• Leads team members to improve and reinforce performance of others
• Takes responsibility for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development
• Other duties as assigned
Physical Requirements
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.
Qualifications
• Education/Experience:
• Bachelor's Degree, required
• Master's Degree, preferred
• 3-5 years of relevant leadership experience
• 5 years GMP or other regulated industry experience, required
• Must be able to read and understand English-written job instructions and safety requirements
• Technical Requirements:
• Excellent written and verbal communication skills with internal and external customers
• Ability to communicate complex technical information to non-technical audiences
• Maintains data integrity and ensure compliance with company SOP's, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
• Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
• Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise
• Begin to provide reliable and defendable interpretations of regulatory guidance for the customer . click apply for full job details
Date Posted: 18 February 2025
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